RecruitingPhase 1NCT07319364

A Real-World Study of Fecal Transplants for Cancer Therapy Side Effects

An Observational, Real-World Study Evaluating Fecal Microbiota Transplantation for the Prevention/Reduction of Chemotherapy/Targeted Therapy-Induced Gastrointestinal Symptoms in Patients With Gastrointestinal Cancers.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

90 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Antineoplastic Agents Gastrointestinal Neoplasms Fecal Microbiota Transplantation (FMT)

Summary

The goal of this clinical trial is to learn if fecal microbiota transplantation can treat in Gastrointestinal cancer patients with chemotherapy / targeted gastrointestinal symptoms. The main question it aims to answer is: To evaluate the effect of fecal microbiota transplantation (FMT) on gastrointestinal tract in patients with gastrointestinal tumors.

Eligibility

Min Age: 18 Years

Inclusion Criteria13

Age ≥ 18 years, gender not restricted;
Estimated survival time ≥ 3 months;
Confirmed diagnosis of gastrointestinal tumors by pathological examination, including esophageal cancer, gastric cancer, colon cancer, rectal cancer, etc.;
TNM staging of cancer in patients is Stage IV;
Having undergone PD-1 or PD-L1 testing;
Planned to receive the 4th cycle of chemotherapy/targeted therapy;
Occurrence of gastrointestinal adverse reactions (including but not limited to diarrhea, constipation, vomiting, nausea, etc.) within 3 cycles of conventional chemotherapy/targeted therapy;
Patients are able and willing to sign the informed consent form and complete follow-up;
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;
Use of oral/intravenous broad-spectrum antibiotics with caution within 3 days;
Patients are able to swallow capsules without chewing;
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;
Laboratory test results during the screening period indicate that the subjects have sufficient organ function.

Exclusion Criteria9

Patients with major organ dysfunction or even failure, including but not limited to cardiac insufficiency or heart failure, renal insufficiency or renal failure, and hepatic insufficiency/hepatic failure;
Uncontrolled or severe infections;
Known history of psychotropic substance abuse, alcoholism, and drug abuse;
Patients with severe infections complicated with septicemia or sepsis;
Patients with a history of severe allergic reactions or a known allergy to the components of liquid live bacteria enteric-coated capsules;
Patients with active viral infections;
Female subjects with a positive pregnancy test, lactating female subjects, and women of childbearing age who refuse to use contraceptive measures during the entire observation period (15 weeks);
Patients with gastrointestinal perforation and/or fistula;
Other conditions deemed unsuitable for enrollment by the investigator.

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Interventions

BIOLOGICALFecal microbiota transplantation (FMT)

Building upon the existing treatment regimen, starting from the fourth cycle, one FMT treatment was administered within 3 days prior to chemotherapy/targeted therapy during the fourth, sixth, and eighth cycles (weeks 3, 9, and 15 after study initiation). Each transplant consisted of approximately 40g of donor intestinal bacteria encapsulated in capsules. The capsules were administered orally, typically at a dose of 2-3 capsules (1g/capsule) every 3-5 minutes, totaling 40 capsules per dose for a total of 120 capsules. Treatment cycles were conducted every 3 weeks, with therapeutic efficacy assessed after every 2 cycles.